Night-eating SyndromeMLTNCT02500017
Melatonin Treatment for Night-Eating Syndrome
A study testing Melatonin in people with Night-eating Syndrome, run by Yale University at 1 site in United States.
Trial summary
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms of Night Eating Syndrome (NES). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Night-eating Syndrome
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2015to 25 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years of age
- English speaking
- Meet DSM-V (Diagnostic and Statistical Manual - version 5) criteria for Night Eating Syndrome (NES)
Who cannot join
- Unable to provide informed consent
- Presence of alcohol/substance dependence
- Presence of other eating disorders such as Binge Eating Disorder, Anorexia Nervosa.
- Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)
- Women who are pregnant or breastfeeding
- Allergy or hypersensitivity to melatonin
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms of Night Eating Syndrome (NES). The investigators will also look at the effect of melatonin treatment on weight, metabolic parameters and sleep parameters in individuals with NES.
Read the detailed description
Night Eating Syndrome (NES) is a unique disorder characterized by a delayed pattern of food intake in which recurrent episodes of food consumption occurs after the evening meal and/or during nocturnal awakenings. Diagnostic criteria for NES include: (1) recurrent episodes of night eating, as manifested by eating after awakening from sleep or by excessive food consumption following the evening meal, (2) awareness of those eating episodes, and (3) significant distress or impairment caused by the disorder. Exclusion criteria are binge-eating disorder or another mental disorder, as well as medical disorders or medications that might better explain the disordered eating pattern. NES is also more common among patients with insomnia, eating disorders, and other psychiatric disorders. 100 participants with night eating syndrome will be recruited from the general population. They will be randomized to either a commercially available rapid-release formulation of melatonin (5 mg) or matching placebo capsules, that will be administered once a day for a total of 8 weeks. Participants will attend a screening appointment, a baseline assessment and additional research assessment visits every other week for the 8 weeks.
- Conditions
- Night-eating Syndrome
- Being tested
- Melatonin, Placebo
- Medical subject headings
- Night Eating Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
5mg rapid release melatonin capsule
PlaceboOther
matching placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | A commercially available rapid-release formulation of melatonin (5 mg) capsules to be administered once a day for a total of 8 weeks Receives: Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Matching placebo capsules to be administered once a day for a total of 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score
Change in total score for the Night Eating Symptom Scale (NESS) from baseline to endpoint. Scores range from 0-52. Lower scores are better than higher scores.
Measured: 8 weeks
Secondary outcomes (3)
Change in body weight in kilograms during study duration.
Change in body weight in kilograms from baseline to endpoint.
Measured: 8 weeks
Change in body mass index (BMI) during study duration
Change in body weight in kilograms from baseline to endpoint.
Measured: 8 weeks
Change in waist circumference in centimeters during study duration.
Change in waist circumference in centimeters from baseline to endpoint.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start24 Sep 2015
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Why it stopped: Difficulty recruiting appropriate participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Night-eating SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Tek, Yale University
- Investigators
- Cenk Tek, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500017
- Sponsor's protocol ID
- 1503015417
- Acronym
- MLT
- Status last verified
- Jan 2018
- First submitted
- 14 Jul 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All de-identified data resulting from this award involving human subjects will be submitted to the NIMH Data Archive (NDA) - National Database for Clinical Trials Related to Mental Illness (NDCT) The Principal Investigator will work with NDA support staff to plan an appropriate data submission schedule and provide information on the steps for submission and sharing of data. Communication of this data sharing plan to appropriate research staff to ensure the timely submission of data. All human subject data provided will include an NDA Global Unique Identifier (GUID) and will not include personally identifiable information (PII). Analyzed data will be submitted no later than the time of publication. Even if a publication focuses on only part of an analyzed dataset, the entire analyzed dataset will be submitted when the first paper is published. All data made available for public use via NDA will be de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Treatment for Night-Eating Syndrome
- ClinicalTrials.gov ID
- NCT02500017
- Acronym / sponsor ID
- MLT / 1503015417
- Conditions
- Night-eating Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting appropriate participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 24 Sep 2015 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms of Night Eating Syndrome (NES). The investigators will also look at the effect of melatonin treatment on weight, metabolic parameters and sleep parameters in individuals with NES.
Detailed description
Night Eating Syndrome (NES) is a unique disorder characterized by a delayed pattern of food intake in which recurrent episodes of food consumption occurs after the evening meal and/or during nocturnal awakenings. Diagnostic criteria for NES include: (1) recurrent episodes of night eating, as manifested by eating after awakening from sleep or by excessive food consumption following the evening meal, (2) awareness of those eating episodes, and (3) significant distress or impairment caused by the disorder. Exclusion criteria are binge-eating disorder or another mental disorder, as well as medical disorders or medications that might better explain the disordered eating pattern. NES is also more common among patients with insomnia, eating disorders, and other psychiatric disorders. 100 participants with night eating syndrome will be recruited from the general population. They will be randomized to either a commercially available rapid-release formulation of melatonin (5 mg) or matching placebo capsules, that will be administered once a day for a total of 8 weeks. Participants will attend a screening appointment, a baseline assessment and additional research assessment visits every other week for the 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Dietary Supplement: MelatoninA commercially available rapid-release formulation of melatonin (5 mg) capsules to be administered once a day for a total of 8 weeks |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo capsules to be administered once a day for a total of 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 - 65 years of age
- English speaking
- Meet DSM-V (Diagnostic and Statistical Manual - version 5) criteria for Night Eating Syndrome (NES)
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Presence of alcohol/substance dependence
- Presence of other eating disorders such as Binge Eating Disorder, Anorexia Nervosa.
- Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)
- Women who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin5mg rapid release melatonin capsule | Dietary supplement | Melatonin |
| Placebomatching placebo capsule | Other | Placebo |
Primary outcome
Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score
Time frame: 8 weeks
Change in total score for the Night Eating Symptom Scale (NESS) from baseline to endpoint. Scores range from 0-52. Lower scores are better than higher scores.
3 secondary outcomes
Change in body weight in kilograms during study duration.
Time frame: 8 weeks
Change in body mass index (BMI) during study duration
Time frame: 8 weeks
Change in waist circumference in centimeters during study duration.
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Difficulty recruiting appropriate participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Yes. All de-identified data resulting from this award involving human subjects will be submitted to the NIMH Data Archive (NDA) - National Database for Clinical Trials Related to Mental Illness (NDCT) The Principal Investigator will work with NDA support staff to plan an appropriate data submission schedule and provide information on the steps for submission and sharing of data. Communication of this data sharing plan to appropriate research staff to ensure the timely submission of data. All human subject data provided will include an NDA Global Unique Identifier (GUID) and will not include personally identifiable information (PII). Analyzed data will be submitted no later than the time of publication. Even if a publication focuses on only part of an analyzed dataset, the entire analyzed dataset will be submitted when the first paper is published. All data made available for public use via NDA will be de-identified data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cenk Tek, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Night-eating Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting appropriate participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.